2024
Supporting diversity in clinical trials: the equitable breakthroughs in medicine site maturity model
Harris T, Nunez-Smith M, Suttiratana S, Fretz S, Leonard S, Linnander E, Curry L. Supporting diversity in clinical trials: the equitable breakthroughs in medicine site maturity model. Trials 2024, 25: 764. PMID: 39543751, PMCID: PMC11566401, DOI: 10.1186/s13063-024-08594-9.Peer-Reviewed Original ResearchConceptsSocial determinants of healthQuantitative self-report dataDeterminants of healthCommunity engagementHealth care providersRepresentation of diverse populationsSelf-reported dataSocial determinantsCare providersContent validityPotential participantsClinical trial capabilitiesClinical trial diversityDiverse populationsInclusion of diverse participantsClinical trialsAssessment of capabilitiesTrial infrastructureDiverse participantsU.S. sitesClinical researchAbstract BackgroundParticipantsDiversity effortsStructural assessmentHarnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies
Miller J, Pelletiers W, Suttiratana S, Mensah M, Schwartz J, Ramachandran R, Gross C, Ross J. Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies. BMJ Medicine 2024, 3: e000920. PMID: 39175919, PMCID: PMC11340651, DOI: 10.1136/bmjmed-2024-000920.Peer-Reviewed Original ResearchUS Food and Drug AdministrationFood and Drug AdministrationClinical trialsReference standardDrug AdministrationInternational Federation of Pharmaceutical ManufacturersTrial designPhases of clinical trialsEuropean Medicines AgencyEnrollment targetsPharmaceutical company websitesTrial recruitmentPatient populationImprove patient awarenessInternational FederationMedicines AgencyWorld Health OrganizationEligibility criteriaCompany policiesDiversity policiesStakeholder guidanceTrialsFDAPharmaceutical Research and Manufacturers of AmericaCharacteristics of participants
2023
Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies
Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.Peer-Reviewed Original Research